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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K092540
Device Name C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER
Applicant
Rsb Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Applicant Contact KAREN WARDEN
Correspondent
Rsb Spine, LLC
8202 Sherman Rd.
Chesterland,  OH  44026 -2141
Correspondent Contact KAREN WARDEN
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received08/19/2009
Decision Date 01/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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